Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021875
Company: CEPHALON
Company: CEPHALON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NUVIGIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
NUVIGIL | ARMODAFINIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
NUVIGIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | AB | Yes | No |
NUVIGIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
NUVIGIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/15/2007 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021875s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021875_nuvigil_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/07/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021875Orig1s023ltr.pdf | |
04/16/2015 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021875Orig1s021ltr.pdf | |
02/09/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/23/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/05/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/13/2012 | SUPPL-17 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf |
01/13/2012 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf |
10/21/2010 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf | |
06/28/2013 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021875Orig1s012ltr.pdf | |
10/21/2010 | SUPPL-8 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf | |
03/26/2009 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021875s006ltr.pdf |
10/21/2010 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/07/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf | |
04/16/2015 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf | |
06/28/2013 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf | |
10/21/2010 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf | |
10/21/2010 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf | |
10/21/2010 | SUPPL-8 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf | |
10/21/2010 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf | |
06/15/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf |
NUVIGIL
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | No | AB | 206069 | AUROBINDO PHARMA LTD |
ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | No | AB | 200751 | LUPIN LTD |
ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
ARMODAFINIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
NUVIGIL | ARMODAFINIL | 50MG | TABLET;ORAL | Prescription | Yes | AB | 021875 | CEPHALON |
TABLET;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | No | AB | 206069 | AUROBINDO PHARMA LTD |
ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | No | AB | 200751 | LUPIN LTD |
ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
ARMODAFINIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
NUVIGIL | ARMODAFINIL | 150MG | TABLET;ORAL | Prescription | Yes | AB | 021875 | CEPHALON |
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | No | AB | 206069 | AUROBINDO PHARMA LTD |
ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | No | AB | 200751 | LUPIN LTD |
ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
ARMODAFINIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
NUVIGIL | ARMODAFINIL | 250MG | TABLET;ORAL | Prescription | Yes | AB | 021875 | CEPHALON |
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 206069 | AUROBINDO PHARMA LTD |
ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 200751 | LUPIN LTD |
ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 200043 | MYLAN PHARMS INC |
ARMODAFINIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 202768 | NATCO PHARMA LTD |
NUVIGIL | ARMODAFINIL | 200MG | TABLET;ORAL | Prescription | Yes | AB | 021875 | CEPHALON |